Cra Ii (Cz) - Sponsor-Dedicated

2+ years

Not Disclosed

Remote, USA

10 Nov. 5, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Research Associate II
Location: Remote (U.S.)
Company: Syneos Health

About Syneos Health

Syneos Health® is a leading global biopharmaceutical solutions organization dedicated to accelerating customer success. We integrate clinical, medical affairs, and commercial insights to deliver impactful outcomes for our customers, placing patients at the center of everything we do. With over 29,000 employees across 110 countries, we’re passionate about simplifying and streamlining our work to make us easier to work with—and easier to work for.

At Syneos Health, we’re driven to change lives by providing innovative solutions that accelerate the delivery of therapies. Join us in making an impact across the world of clinical research.

Position Overview

We are seeking a Clinical Research Associate II (CRA II) to join our team. In this role, you will ensure the successful monitoring and management of clinical trials, performing site management activities from qualification and initiation to close-out, while ensuring compliance with regulatory requirements, ICH-GCP, and protocol adherence. You’ll also provide valuable site support and work closely with cross-functional teams to meet study goals. This position requires travel (up to 75%) for site visits.

Key Responsibilities

Site Monitoring & Management

Perform site qualification, initiation, interim monitoring, and close-out visits (both onsite and remotely), ensuring adherence to ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and study protocols.
Evaluate site and site staff performance, offering recommendations for improvement and escalating serious issues as needed.
Ensure informed consent is appropriately obtained and documented for each patient, safeguarding confidentiality and subject safety.
Monitor clinical data for integrity, reviewing source documents and ensuring case report form (CRF) data accuracy.
Resolve data queries remotely or onsite, providing guidance to site staff to close queries within agreed timelines.
Verify investigational product (IP) handling, including inventory, storage, and administration in accordance with protocol.

Site File & Documentation

Regularly review the Investigator Site File (ISF) for completeness and accuracy, reconciling it with the Trial Master File (TMF).
Ensure that all essential documents are archived according to local regulatory guidelines and the study’s requirements.
Maintain accurate documentation of monitoring activities, including trip reports, follow-up letters, confirmation letters, and communication logs.

Project & Site Support

Assist with subject recruitment and retention strategies, ensuring the site meets enrollment targets.
Serve as the primary liaison for site personnel, ensuring proper training and compliance with study requirements.
Ensure all assigned sites and site team members are well-prepared for audits and maintain audit readiness at all times.
Participate in Investigator Meetings and global clinical monitoring/project meetings, and provide input for continuous process improvement.
Track the status of site-related activities, ensuring all issues are addressed, resolved, and documented.

Real World Late Phase Studies (for relevant studies)

Support throughout the study lifecycle, from site identification to close-out.
Assist with chart abstraction activities, and collaborate with sponsor affiliates and medical science liaisons.
Identify and communicate potential out-of-scope activities to senior project staff.
Provide training to junior staff and assist with the proactive selection of study sites based on local knowledge and expertise.

Qualifications

Education & Experience

Bachelor’s degree or equivalent in a related field (e.g., Life Sciences, Nursing).
Previous experience as a Clinical Research Associate with hands-on monitoring experience (at least 12 months).

Technical Competencies

In-depth knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
Strong computer skills, with the ability to embrace new technologies and systems (e.g., CTMS, EDC).
Investigational Product handling and reconciliation knowledge.
Familiarity with electronic data capture and ensuring site compliance.

Behavioral Competencies

Excellent communication, presentation, and interpersonal skills.
Ability to manage up to 75% travel, depending on project needs.
Strong organizational skills and the ability to prioritize effectively in a dynamic work environment.
Adaptable to changing priorities and willing to collaborate in a team environment to meet project goals.

What Syneos Health Can Offer You

Syneos Health values its employees and offers an inclusive environment with diverse career development opportunities. Our Total Self culture fosters personal and professional growth, and our Total Rewards program is designed to reward success while prioritizing well-being.

We offer:

Competitive salary and annual leave entitlements
Comprehensive health insurance options to meet your and your family’s needs
Retirement planning options to help you save for the future
Employee Assistance Program (EAP) for health and wellness support
Flexible benefits such as childcare vouchers, gym memberships, and more

Why Work for Syneos Health?

Syneos Health is driven by the desire to make an impact. With over 29,000 employees across 110 countries, we support over 200 studies and have worked with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products in the last 5 years. Join us in accelerating the delivery of therapies that improve lives worldwide.

Syneos Health is an Equal Opportunity Employer
We are committed to creating a workplace free of discrimination and harassment. All qualified applicants will be given equal consideration for employment, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. We also provide reasonable accommodations as needed for applicants with disabilities.